Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma

NCT05644743 | Not Yet Recruiting

• 1 other identifier: 202240313
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The clinical incidence of intrahepatic cholangiocarcinoma (ICC) is high and insidious, and the prognosis of advanced patients is poor. The clinical manifestations of traditional chemotherapy GC and emerging targeted therapy are different in most patients, and there is still no effective scheme to evaluate the differences in individual patient reactivity. Patient-derived tumor organoids (PDO) are 3D-cultured tissues based on tumor cell dryness that reproduce a variety of biological characteristics of parental tumors in vitro and have similar drug responsiveness to tumors in vivo. This project plans to use clinical cases and optimized organoid culture system to first construct relevant organoids from unresectable ICC patient puncture samples. Secondly, based on the organoid model of intrahepatic cholangiocarcinoma, the clinical efficacy of GC regimen was predicted, and in vitro and in vivo drug screening was conducted to explore the guidance of patient-derived tumor organoids for clinical treatment. Then, multi-omics data of organoids and in vitro and in vivo drug efficacy evaluation model were used to explore the drug resistance genes of intrahepatic cholangiocarcinoma, providing the basis for personalized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma.

Conditions

Organoids; Intrahepatic Cholangiocarcinoma

Keywords

Organoid

Outcome Measures

Primary Outcomes (2)

• Consistency of organoids and clinical patient responses to drugs

  A total of 20 unresectable ICC patients were selected and biopsies were performed before treatment to construct organoid models. All patients were treated with GC chemotherapy. Drug responses of organoids and clinical patients were compared to determine the feasibility of in vitro organoid culture as a drug screening platform. The samples of 3 patients who were sensitive to GC and 3 patients who were resistant to GC were sequenced to search for drug-resistant genes, and the differential drug-resistant genes were studied in vitro.

  3 years

• Construction of drug resistance prediction model

  A total of 20 patients with advanced unresectable ICC were selected to verify whether they participated in drug resistance by combining 1-2 drug resistance genes previously screened and the currently recognized platinum-based drug resistance genes. The results were compared with those of organoid models to build an organoid-based drug resistance prediction model.

  3 years

Interventions

gemcitabine + cisplatin DEVICE

Gemcitabine intravenous drip, day 1, 8； Cisplatin intravenous drip, day 1； 3 weeks is a cycle, and 6 cycles are used continuously.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients were histologically or cytologically diagnosed with locally advanced inoperable radical resectable or metastatic intrahepatic cholangiocarcinoma.

You may qualify if:

• \- Histologically confirmed intrahepatic cholangiocarcinoma They are between 18 and 80 years old Written informed and signed consent form Biopsy sample of the intrahepatic bile duct

You may not qualify if:

• \- Under 18, over 80 Informed consent cannot be given Biopsy samples were not available

Sponsors & Collaborators

• Chengjun Sui,MD: lead

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• chengjun sui, dr.

  Deputy director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhitao dong, dr.

CONTACT

+86-021-81875554; dongzt2012@126.com

kunpeng fang, dr.

CONTACT

+86-021-81875553; Wuguoz2011@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of the Special Needs Division

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2022

Record last verified: 2022-11